Phyllis Viola Log

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Phyllis Viola Log


My research topic is looking in dept into the pharmaceutical patent process and focus on one particular drug.

The link to my article is
http://news.bna.com.ezproxy2.library.drexel.edu/piln/PILNWB/split_display.adp?fedfid=17304323&vname=plirnotallissues&wsn=518916000&searchid=18974848&doctypeid=1&type=date&mode=doc&split=0&scm=PILNWB&pg=0.


I need help find DOI's
.

"In Wins for Sanofi, District Court Blocks Dr. Reddy's Introduction of Generic Allegra-D" by Dana Elfin

  • On June 14, 2010, Dr. Reddy's Laboratories Inc. was barred from selling their generic Allegra-D.
  • This comes shortly after a temporary restraining order that was put in place on June 2, 2010.
  • Dr. Reddy's Laboratories Inc. is the approved supplier for the active pharmaceutical ingredient (API).
  • Albany Molecular Research Inc. (AMRI) was content with the upholding of their intellectual property rights.
  • Dr. Reddy's company plans to appeal the decision.
  • Dr. Reddy's was caught by applying for a abbreviated new drug application. This would allow for them to sell generic versions of Allegra and Allegra-D in the United States.
  • The patent number is 7,390,906 and was issued in 2008.
  • AMRI believes that the selling of a generic version of Allegra by Sandoz would be patent infringement.
  • Since Dr. Reddy's Laboratories Inc. is the API, they are also liable for patent infringement.
  • The patent is for the process of creating Allegra with a cyclopropyl ketone intermediate (CPK).
  • The reason why Dr. Reddy's Laboratories Inc. is liable is because of using the same CPK intermediate.
  • Dr. Reddy's Laboratories Inc. tried to argue that the term "substantially pure" was a major difference from the original patent.
  • Judge Brown disagreed and believed that all terms were unambiguous.
  • Judge Brown argues that the para CPK compound can be produced without being put into a pure form but by just in a regioisomeric mixture.
  • Judge Brown found in favor of AMRI and Sanofi.
  • Judge Brown had to first determine if that plaintiffs had a reasonable case.
  • This was helped proved by expert testimony.
  • Judge Brown then had to determine if either party would be "irreparably" damage. For AMRI, Brown believed that the brand injury would be too great to allow the generic drug to be sold.
  • Judge Brown had to lastly reduce the disparity of equities and public interest.
  • The equities of Dr. Reddy's Laboratories Inc. would be unjustly shifted forward in time therefore not fair to AMRI.
  • When a court has to choose between patent rights and a lower priced generic drug, the court will always favor patent rights.